MMD-103    Understanding of USFDA CFR Title 21 Part 820 Quality System                                       Regulation

  • Overview
  • Course Objectives
  • Course Content
  • For Whom
  • Schedule and Hours
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ll medical device manufacturers supplying medical devices to the U.S. are required to maintain a quality management system in compliance with the Code of Federal Regulations (CFR) Title 21, otherwise known as 21 CFR 820. The quality management system requirements cover a broad range of areas, including production and process controls, corrective and preventive actions, product development and management.
To understand the requirements of USFDA CFR Title 21 Part 820 Quality System Regulation for effective implementation and compliance.
  •  Introduction on USFDA
  • Medical devices regulated by USFDA
  • Understanding of:
            Subpart A - General Provisions
            Subpart B - Quality System Requirements
            Subpart C - Design Controls
            Subpart D - Document Controls
            Subpart E - Purchasing Controls
            Subpart F - Identification and Traceability
            Subpart G - Production and Process Controls
            Subpart H - Acceptance Activities
            Subpart I - Nonconforming Product
            Subpart J - Corrective and Preventive Action
            Subpart K - Labeling and Packaging Control
            Subpart L - Handling, Storage, Distribution, and Installation
            Subpart M - Records
            Subpart N - Servicing
            Subpart O -Statistical Techniques
  • How to survive an USFDA inspection?​
For all personnel who involved in the organizations that are required to conform with USFDA CFR Title 21 Part 820 Quality System Regulation.
This is a 2-days programme.
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This course runs from 9:00am – 5:00pm with an hour for lunch and periodic short breaks.
 
This is an intensive session designed to include as much discussion as possible. Lunch and breaks provide an opportunity for further questioning and discussion with the instructors.

We are HRD Corp (Human Resource Development Corporation) Registered Training Provider.
​All of our training modules are claimable under HRD Corp.